Medtronic Vascular recalls specific SHERPA NX Active Guiding Catheters for potential wire exposure risk during cardiovascular procedures.
There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa catheters.
Medtronic Vascular is recalling certain SHERPA NX Active Guiding Catheters used in cardiovascular procedures. The recall is due to a risk of stainless steel wires becoming exposed, which could cause complications during medical procedures.
The catheter's primary segment material can become exposed, revealing underlying stainless steel braid wires. This could lead to complications during medical procedures if the wires are inadvertently manipulated.
Healthcare professionals using the specific catheter model for cardiovascular procedures are most at risk. Patients undergoing procedures with this catheter may also be affected.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F JR3.5 SH, .070", and reference number SA6JR35SH. The product was sold with a GTIN: 00613994822352.
Identify the model, size, and reference number to confirm if your catheter is affected.
The recall indicates a potential risk, so it is recommended to check if your catheter is affected before use.
The recall does not specify a remedy, so contact Medtronic Vascular directly for guidance.
Check for the model name 'SHERPA NX ACTIVE GUIDING CATHETER', size 6F JR3.5 SH, .070", and reference number SA6JR35SH.
We’ve drafted a message you can send Medtr: Vascular to request your refund or repair — edit it as you like.
Subject: Recall Z-2644-2019 — Medtr: Vascular Medtr: Vascular Hello, I own a Medtr: Vascular that is covered by recall Z-2644-2019 from Medtr: Vascular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
